Transpire Bio, a clinical-stage biopharmaceutical company, shared that its abbreviated new drug application for fluticasone furoate, umeclidinium and vilanterol inhalation powder has been accepted for ...
Au8, an experimental ALS therapy. CNM-Au8 has been associated with NfL reductions, a biomarker finding linked to longer ...
FDA filing covers renewal applications for VLN® King and VLN® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway ...
Regulatory green light: FDA agreed to include Phase 2 and Phase 3 data in MoonLake's Sonelokimab label for hidradenitis suppurativa, with no gaps blocking filing. Broader patient reach: Support for ...
The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...
When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when ...
The Food and Drug Administration (FDA) has issued a Refuse-to-File (RTF) letter to Moderna, Inc. regarding its Biologics License Application (BLA) for the investigational mRNA-based influenza vaccine ...
MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...
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